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Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02289248
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
Subjects with depressive episodes will be recruited to undergo a brief 2 week course of IV infusions of ketamine in combination with cognitive behavioral therapy for 8 weeks.

Condition or disease Intervention/treatment Phase
Depression Drug: Ketamine Behavioral: Cognitive Behavioral Therapy (CBT) Phase 1

Detailed Description:
Twelve subjects with current diagnosis of depressive episode will be recruited to undergo a brief course of 4 intravenous infusions of ketamine, given twice weekly for two weeks in combination with CBT, given twice weekly. The CBT course will be 16 total sessions (given over 8 weeks), will begin the day following the initial ketamine infusion, and will be performed by a therapist who has successfully completed extensive training at the Beck Institute for Cognitive Therapy and Research and has experience with similar studies. Homework assignments will include thought records and activity charts which are used in standard practice to facilitate CBT interventions.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy in Prolonging the Antidepressant Effects of Intravenous Ketamine
Study Start Date : February 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine/CBT Group
Subjects will undergo 2 week course of 4 intravenous infusions of ketamine (given twice weekly for two weeks) in combination with twice weekly cognitive behavioral therapy for a total of 8 weeks.
Drug: Ketamine
Subjects will undergo a twice weekly two week course of IV infusions of ketamine

Behavioral: Cognitive Behavioral Therapy (CBT)
Subjects will undergo twice weekly CBT for a total of 8 weeks




Primary Outcome Measures :
  1. Extinction Learning Task performance [ Time Frame: 24 hours Post ketamine infusion ]
    Hopkins Verbal Learning Test and extinction learning tasks will be administered both one week before and 24-hours after the first ketamine infusion and the change in scores compared.


Secondary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ]
    Change in MADRS from baseline through week eight using a random effects model



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suffering from a depressive episode (DSM 5; either Major Depressive Disorder or Bipolar Disorder) and having failed one or more standard antidepressant treatments during the current episode;
  • Age 18-65;
  • Hamilton Depression Rating Scale (17-HAM-D) score of 21 or more prior to study entry.

Exclusion Criteria:

  • Any Axis I or Axis II Disorder, which at screening is clinically predominant to their depressive episode or has been predominant to their depressive episode at any time within 6 months prior to screening;
  • Active suicidal thoughts with a plan; current or recent (<6 months ago) substance use disorder;
  • Non-affective psychosis (such as schizophrenia or schizoaffective disorder);
  • Pregnancy or breastfeeding;
  • Inability to speak English fluently;
  • A clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results;
  • A history of CBT treatment in the past 12 months;
  • Dementia;
  • Delirium;
  • Any other neurological or mental disease that might affect cognition or the ability to meaningfully participate in CBT.
  • Untreated hypertension as defined by a systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg at screening on two of three measurements.
  • Recent myocardial infarction (within one year)
  • Syncopal event within the past year.
  • Congestive heart failure (CHF) New York Heart Association Criteria >Stage 2
  • Angina pectoris.
  • Heart rate <50 or >105 beats per minute at screening

Females are eligible provided they meet criteria A or B below:

  1. Non-childbearing potential: e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or is post-menopausal with her last menses at least one year prior to screening; or
  2. Childbearing potential, and meets the following criteria:

i. Childbearing potential, including women using any form of hormonal birth control, on hormone replacement therapy started prior to 12 months of amenorrhea, using an intrauterine device (IUD), having a monogamous relationship with a partner who has had a vasectomy, or is sexually abstinent.

ii. Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test at enrollment prior to receiving study treatment.

iii. Willing and able to continuously use one of the following methods of birth control during the course of the study, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly: implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence. The form of birth control will be documented at screening and baseline.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289248


Locations
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United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Yale Psychiatric Hospital
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Samuel Wilkinson, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02289248     History of Changes
Other Study ID Numbers: 1501015171
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Ketamine
Antidepressive Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Psychotropic Drugs